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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
The study design is a retrospective case-note series of patients that have undergone reinforcement of soft tissues with Safil® Mesh after abdominal wall surgery or other fascial defects between the period January 2019 - November 2020
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safil Mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hernioplasty | Device | Hernioplasty is the repair of the defect using mesh patches. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hernia rate | Rate of hernias occuring during follow-up of retrospectively included patients | at one follow-up 12-30 months after initial intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative complications | Retrospective documentation of Number of Participants with intraoperative Complications | intraoperatively |
| Post-operative complications | Number of retrospectively included participants having complications during follow-up of |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data of the patient: age | Retrospective documentation of Demographic data of the patient for descriptive purposes: age of patients at time of surgery | preoperatively |
| Demographic data of the patient: sex |
Inclusion Criteria:
Exclusion Criteria:
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Patients operated between January 2019 - November 2020 for abdominal wall surgery or other fascial defects and received Safil® Mesh
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| Name | Affiliation | Role |
|---|---|---|
| Izaskun Badiola Bergara, Dr. | Hospital Galdakao-Usansolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Galdakao-Usansolo | Galdakao | Bizkaia | 48960 | Spain | ||
| Hospital Universitario de Salamanca |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059685 | Herniorrhaphy |
| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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| at one follow-up 12-30 months after initial intervention |
| Reintervention rate | Complications leading to reintervention during follow-up of retrospectively included patients | at one follow-up 12-30 months after initial intervention |
Retrospective documentation of Demographic data of the patient for descriptive purposes: sex
| preoperatively |
| Demographic data of the patient: weight | Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index | preoperatively |
| Demographic data of the patient: height | Retrospective documentation of Demographic data of the patient for descriptive purposes: weight and height are documented to calculate body mass index | preoperatively |
| Demographic data of the patient: general health status | Retrospective documentation of Demographic data of the patient for descriptive purposes: general health status according to ASA classification (ASA I: healthy patient; ASA II: A patient with mild systemic disease; ASA III: A patient with severe systemic disease; ASA IV: A patient with severe systemic disease that is a constant threat to life; ASA V: A moribund patient who is not expected to survive without the operation) | preoperatively |
| Demographic data of the patient: risk factors | Retrospective documentation of Demographic data of the patient for descriptive purposes: risk factors (smoker, alcohol abuse, previous surgery of abdominal hernia, chronic immunosuppression, chronic cortison treatment, abdominal aortic aneurysm, anticoagulantic treatment) | preoperatively |
| Surgery details: Type of intervention | Retrospective documentation of surgery details for descriptive purposes: Type of intervention (elective / emergency) | intraoperative |
| Surgery details: access | Retrospective documentation of surgery details for descriptive purposes: access (open / laparoscopic / laparoscopic with conversion) | intraoperative |
| Surgery details: anesthetics | Retrospective documentation of surgery details for descriptive purposes: anesthetics (general / regional / local) | intraoperative |
| Surgery details: duration of surgery | Retrospective documentation of surgery details for descriptive purposes: duration of surgery | intraoperative |
| Surgery details: details on implanted mesh | Retrospective documentation of surgery details for descriptive purposes: details on implanted mesh (number / sizes) | intraoperative |
| Surgery details: closure technology | Retrospective documentation of surgery details for descriptive purposes: closure technology (absorbable suture, non absorbable suture, single-knot, continuous suture, adhesives) | intraoperative |
| Salamanca |
| 37007 |
| Spain |